How are Alendronate Sodium adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Alendronate Sodium, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Alendronate Sodium is flagged as the suspect drug causing the adverse event.
What are the most common Alendronate Sodium adverse events reported to the FDA?
Femur Fracture | 2153 (6.97%) |
Low Turnover Osteopathy | 903 (2.92%) |
Stress Fracture | 714 (2.31%) |
Bone Disorder | 707 (2.29%) |
Fall | 619 (2%) |
Arthralgia | 404 (1.31%) |
Fracture | 340 (1.1%) |
Pain In Extremity | 332 (1.07%) |
Anxiety | 300 (.97%) |
Pain | 266 (.86%) |
Osteoarthritis | 261 (.84%) |
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This graph shows the top adverse events submitted to the FDA for Alendronate Sodium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Alendronate Sodium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.
What are the most common Alendronate Sodium adverse events reported to the FDA?
Bone And Joint Injuries | 4271 (13.82%) |
Bone Disorders | 2511 (8.13%) |
Joint | 1444 (4.67%) |
Infections - Pathogen Unspecified | 1279 (4.14%) |
Injuries | 1130 (3.66%) |
Musculoskeletal And Connective Tiss... | 957 (3.1%) |
Dental And Gingival Conditions | 671 (2.17%) |
Gastrointestinal Signs | 616 (1.99%) |
Anxiety Disorders | 540 (1.75%) |
Epidermal And Dermal Conditions | 536 (1.73%) |
Neurological | 508 (1.64%) |
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This graph shows the top categories of adverse events submitted to the FDA for Alendronate Sodium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Alendronate Sodium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.
Why are people taking Alendronate Sodium, according to those reporting adverse events to the FDA?
Osteoporosis | 4112 |
Drug Use For Unknown Indication | 1006 |
Osteopenia | 996 |
Product Used For Unknown Indication | 628 |
Osteoporosis Prophylaxis | 525 |
Prophylaxis | 199 |
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Label | Labeler | Effective |
---|---|---|
Alendronate Sodium | SUN PHARMA GLOBAL INC. | 11-APR-09 |
Alendronate Sodium | Cobalt Laboratories Inc. | 28-OCT-09 |
Alendronate Sodium | Dispensing Solutions Inc. | 28-JAN-10 |
Alendronate Sodium | Rebel Distributors Corp | 26-JAN-11 |
Alendronate Sodium | Cobalt Laboratories Inc. | 27-APR-11 |
Alendronate Sodium | UDL Laboratories, Inc. | 06-MAY-11 |
Alendronate Sodium | Watson Laboratories, Inc. | 21-JUL-11 |
Fosamax Plus D | Physicians Total Care, Inc. | 20-DEC-11 |
Alendronate Sodium | Jubilant Cadista Pharmaceuticals Inc. | 01-FEB-12 |
Fosamax Plus D | Merck Sharp & Dohme Corp. | 29-FEB-12 |
Alendronate Sodium | Apotex Corp. | 10-APR-12 |
Alendronate Sodium | Physicians Total Care, Inc. | 24-APR-12 |
Alendronate Sodium | American Health Packaging | 22-JUN-12 |
Binosto | Mission Pharmacal Company | 26-JUN-12 |
Fosamax | Merck Sharp & Dohme Corp. | 27-JUN-12 |
Alendronate Sodium | Aurobindo Pharma Limited | 02-AUG-12 |
Alendronate Sodium | Ascend Laboratories, LLC | 14-AUG-12 |
Alendronate Sodium | Mylan Pharmaceuticals Inc. | 31-AUG-12 |
Alendronate Sodium | NorthStar Rx LLC | 06-NOV-12 |
Alendronate Sodium | Teva Pharmaceuticals USA Inc | 20-DEC-12 |
Alendronate Sodium | Blu Pharmaceuticals, LLC | 31-JAN-13 |
Alendronate Sodium | Apotex Corp. | 01-FEB-13 |
Fosamax | Merck Sharp & Dohme Corp. | 19-APR-13 |
Fosamax Plus D | Merck Sharp & Dohme Corp. | 19-APR-13 |
What Alendronate Sodium safety concerns are being reported by doctors and researchers in the medical literature?
This report contains aggregated drug side effects and adverse events for Alendronate Sodium. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.
DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.
DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.
Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.
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